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|Mallinckrodt States its Position on Legacy Acthar® Gel Legal Matter|
- Original action filed in 2012, prior to Mallinckrodt's ownership
of Acthar Gel
April 30, 2019
Recently a legacy legal matter stemming from allegations filed against the prior owner of Acthar® Gel became public, and recent news stories have conveyed those allegations. The company believes it is important to state its position on this matter.
The U.S. Department of Justice (DOJ) elected to join an existing civil False Claims Act case against the company, which has been unsealed by a court in the Eastern District of Pennsylvania. The original action was filed in 2012, prior to Mallinckrodt's ownership of Acthar Gel, and consists of two complaints filed by former Questcor employees. Questcor was the previous owner of Acthar Gel. The allegations pertain principally to legacy Questcor conduct.
Importantly, Mallinckrodt strongly disagrees with the substance of the complaints and the sensational characterization of the allegations.
Mallinckrodt has cooperated fully with the DOJ in its review of this historical conduct, voluntarily providing documents and information to the government. While we are disappointed the DOJ has elected to proceed with the lawsuit, we have been in advanced settlement talks with the government over the past several months.
The company believes these sales and marketing claims are likely to be resolved in the near term through ongoing negotiations, and further believes a resolution that is reasonable and manageable for all parties is achievable.
As the lawsuit principally concerns allegations of legacy conduct prior to Mallinckrodt's acquisition of Acthar Gel, the company does not envision any impact to how Mallinckrodt conducts business today.
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